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2023 Joint UNICEF-UNFPA-WHO Meeting with Manufacturers and Suppliers

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27 November - 1 December, 2023 - 08:00 - 19:00 (CET)
Denmark

The 2023 Joint UNICEF-UNFPA-WHO Meeting with Manufacturers and Suppliers took place from Monday, 27 November to Friday, 1 December 2023 at UN City, Marmorvej 51, 2100 Copenhagen, Denmark.

The theme of the 2023 Joint UNICEF-UNFPA-WHO Meeting was: "A nexus for promoting equitable access to quality health products”. Narrative: Sustainable universal health coverage requires innovation and collaboration. 

Kindly see below Agenda and Presentations of the 2023 Joint UNICEF-UNFPA-WHO Meeting with Manufacturers and Suppliers. For any further information and/or clarification, please do not hesitate to contact the WHO Prequalification Unit (PQT) at: prequal@who.int 

 

Agenda


Presentations

Day 1

Session 1

  1. Opening
  2. Meeting Objectives and Outline

Session 2

  1. Aligning WHO Normative and Prequalification Processes
  2. Update and progress on the Coordinated Scientific Advice (CSA)
  3. New products pipelines - AMR
  4. New products pipelines - HIV-Hep-STI
  5. New products pipelines - TB
  6. New products pipelines - HIV-TB-Malaria
  7. New products pipelines - Malaria

Session 3

  1. Outcomes from the 2nd World Local Production Forum
  2. UNICEF roadmap on local production and local procurement - Building on progress to date

Session 4

  1. The Verification and Traceability System (TRVST)
  2. Strengthening national capacity for quantification of reproductive health products
  3. Improving sustainable access to antibiotics through market intelligence and coordination
  4. MedSIN - Medicine Shortage Intelligence Network
Day 2

Local Production and Assistance (LPA)

  1. Local Production and Assistance
  2. PQ/EUL- related specialized technical assistance overview
  3. PQ/EUL - related specialized technical assistance for diagnostics
  4. Specialized technical assistance for medicines
  5. Specialized technical assistance for vaccines

Prequalification of In Vitro Diagnostics (PQT/IVD)

  1. Prequalification of in vitro diagnostics - Updates on 2023 achievements and the way forward

Prequalification Inspection Services (PQT/INS)

  1. Update on PQ Inspections - 2022-2023 highlights & Importance of being inspected by WHO PQT
  2. Inspection Trends of Pharmaceutical Manufacturing Sites APIs and FPPs
  3. Trends in the inspection of CROs
  4. Trends in the inspection of Vaccine manufacturing sites
  5. Trends in inspections of diagnostics
  6. Trends in Vector Control Product Inspections
  7. ePQS and eCTD – Inspection Services
  8. Updates on recent guidance published and impact on GMP inspections

Prequalification of Medicines (PQT/MED)

  1. Prequalification Team Medicines - Update
  2. Prequalification Medicines Updates - FPP Quality
  3. API Assessment Update & ePQS update
  4. Bioequivalence Assessment Update
  5. Prequalification of biotherapeutic and biosimilar products
  6. Update on WHO Public Assessment Reports (WHOPARs)

Prequalification of Vaccines (PQT/VAX)

  1. WHO vaccines PQ overview
  2. Quality requirements for prequalification (CMC)
  3. Clinical requirements
  4. Programmatic Suitability for Prequalification (PSPQ)
  5. Risk benefit assessment procedures - updates on EUL
  6. ePQS & eCTD

Prequalification of Vector Control Products (PQT/VCP)

  1. PQT/VCP Updates

United Nations Population Fund (UNFPA)

  1. Updates from the WHO/UNFPA Prequalification Programme for Contraceptive Devices
  2. Review of quality complaints
  3. Review of Changes
  4. Post Market Surveillance of Prequalified Manufacturers
  5. Technical support for new PQ applications – overview/outline, eligibility, implementation
  6. New and innovative technologies for non-systemic contraceptives and STI barrier prophylactics
  7. IUDs - Development and challenges
  8. Impact assessment of WHO/UNFPA Prequalification Programme (Condoms and IUDs)
Day 3

Procurement Updates

  1. WHO Procurement & Supply Services
  2. Global Fund Procurement & Supply Updates
  3. Promoting Access to TB Products: GDF’s 2023 Updates
  4. UNFPA Procurement Updates
  5. UNICEF Procurement Updates
  6. Medical Procurement in UNHCR (from PH Perspective)
  7. UNDP Global Health Procurement and Supply Chain Architecture
  8. PAHO - Regional Revolving Funds

UNFPA

  1. Contract Management: Case Studies
  2. Common Quality Issues - Complaints and Recalls
  3. UNFPA Global Prepositioned Stock
  4. Supply Chain Management Unit
  5. UNFPA Emergency Procurement

UNICEF 

  1. Updates of Unicef Quality Requirements and Tools, Demonstration of Supplier Document Library
  2. Common Quality Issues - Challenges
  3. Common Issues in Procurement and Contract Management: Case Studies from Long Term Agreements and Purchase Orders
  4. GS1 compliance with Packing, Packaging and Labelling
  5. Changes to the UNICEF Bid Form
  6. Invoice Submission Channels
  7. Supply Strategic Framework 2022 –2025
Day 4

Regulatory Updates

  1. Regulatory Updates
  2. Pharmacovigilance
  3. DEG/EG Contamination of Medical Products: Current Situation
  4. Nitrosamines Exchange: A Global Knowledge Hub
  5. Update on Norms and Standards for Pharmaceuticals
  6. WHO Biological Standardization: An update

Treatment and Diagnostic Guidelines, Essential Medicines Lists (including for children), Essential In Vitro Diagnostics List

  1. Update on WHO TB Guidelines
  2. New in Clinical Guidelines: HIV and STIs
  3. COVID therapeutic guidance and the process for the new influenza guideline
  4. WHO Consolidated Guidelines for Malaria
  5. Update on viral hepatitis B and C – diagnostics and treatment
  6. Clinical Guidelines, Essential Lists: Noncommunicable Diseases
  7. WHO Model List of Essential Medicines
  8. Fourth WHO Model List of Essential In Vitro Diagnostics (EDL 4)

Requirements for Storage and Transportation of Time and Temperature Sensitive Health Products

  1. UNICEF Global Transport Center
  2. UNFPA’s risk based approach to quality control and monitoring of time and temperature sensitive health products
  3. GDF’s experience in transport of medical products: challenges and opportunities

Closing Session

  1. Closing Session